Doctors for truth?

By Dahli Aspillera

February 14, 2018

DR. Walden Bello, Ph.D., author of the below statement, was a member of the Philippine House of Representatives from 2009 to 2015. He resigned on principle from Congress, owing to differences with the administration of former president Benigno Aquino III on the Disbursement Acceleration Program (DAP), the Mamasapano Raid, and the Enhanced Defense Cooperation Agreement with the United States. His is the only recorded resignation-on-principle in the history of the Philippine Congress.

Citations in his statement directed me to another stakeholder in the tragedy--Dr. Maria Rosario Capeding--who wrote, with others, the “Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomized, observer-masked, placebo-controlled trial.”--Lancet 2014; 384:1358-65. Dr. Capeding figured prominently in last December’s Dengvaxia inquiries.

Dr. Bello’s statement, on the Dengvaxia tragedy, initially released by Rappler: The Social News Network--below excerpted for limited space:

...There is in the “Doctors for Truth” position paper an implicit defense of the principals on the grounds that “there is no perfect vaccine.” The doctors conveniently forget that the purpose of rigorous clinical trials before a drug is brought to market is to reduce to as close to zero as possible the likelihood that, a) the drug will not work, or that b) it is dangerous, or that c) it has destabilizing side effects.

Measured by the yardstick of accepted statistical probabilities, Dengvaxia failed resoundingly, an event that is rigorously documented and explained in a Research Report that appeared in one of the leading journals of medical research, New England Journal of Medicine (Vol 373, No. 13, Sept 24, 2015), about half of whose authors were connected with Sanofi Pasteur.

The Report, which appeared before the Sanofi contract was made and the vaccination program was implemented, revealed that clinical trials showed that previously uninfected children of a certain age group showed a disturbingly higher risk than previously infected children to contract severe dengue after being vaccinated.

Indeed, so concerned were the editors that they accompanied the article with an editorial titled, “A Candidate Vaccine Walks a Tightrope.” According to the editorial, which hit the dengue research field like a thunderbolt, “Most eye-catching is the suggestion that CYD-TDV [Dengvaxia] vaccination was associated with an elevated risk of hospitalization for dengue among children younger than 9 years of age (but most markedly, among those 2 to 5 years of age) when they were naturally infected in the third year after vaccination.”

It concluded that “we still lack definitive immune correlates of protection or vaccine-associated disease risk. A lesson from these trials, and from our understanding of the natural history of dengue epidemiology, is that partial, waning immunity is a particularly unwelcome outcome after vaccination…Live vaccines need to be sufficiently potent in their infectiousness and replicative capacity to initiate immunity in both unexposed recipients and those with partial immunity…The bumpy road to a vaccine-based solution for dengue continues.”

Despite this red light from a high-powered research team that included its own researchers, Sanofi Pasteur rushed a flawed product to the market to beat the competition and the DOH authorities pushed the vaccine on over 800,000 children in 2016, with no investigation of whether or not they had been previously exposed to dengue. One does not need to be a medical expert to come to the conclusion that the haste with which this vaccine was brought to the field was simply inexplicable from a public health point of view.

It’s a safe bet that very few of the doctors who signed the statement took the time to read the New England Journal of Medicine research report and editorial, for no self-respecting medical professional with the least bit of acquaintance with these documents, would have attached his or her signature to a statement that blithely defends the principals on the ground that “there is no perfect vaccine.”

The signatories compound their irresponsibility by saying that “we urge the DOH not to remove the vaccine from the market altogether,” allegedly to provide protection for those not yet found to be at risk of severe dengue infection stemming from vaccination. But contrary to its previous claim that Dengvaxia provided “consistent efficacy and longer-term safety profile in a study population 9 to16 years of age,” Sanofi retreated from this assertion and attached no age exemptions in its later, November 29, 2017, statement as to who should not be administered the vaccine.

Moreover, in banning the vaccine from the market altogether, the current DOH leadership is not panicking but simply adhering to the time-honored precautionary principle, which says, in this particular instance, that just because severe dengue infection has not yet surfaced in some categories of tested subjects that have been vaccinated does not mean that it is safe for the people in the same categories in the general population to use it.

The finding that those vaccinated who had no previous dengue infection could incur severe dengue demands that administering the drug to all age categories in the population, whether they have been previously infected by dengue or not, should be immediately withheld on the grounds that loss of immunity and susceptibility to severe dengue might take longer to emerge among some categories of the tested subjects. This does not mean a permanent ban, but one that can only be lifted after more rigorous trials carried out over a long period of time prove that the vaccine is safe for all age groups of previously infected or non-infected people.

The signatories bemoan the “expert bashing” that is taking place in public hearings. Have they asked themselves why this bashing is taking place in the first place? The distrust of experts stems from the fact that in the case of Dengvaxia, the experts have so spectacularly failed the people on a matter of public trust: the experts in Sanofi for rushing a dangerous vaccine to the market, and the experts at the DOH for carrying out a mass vaccination program that they knew – or should have known given the published findings--carried grave dangers for many of its intended recipients....

...But with the absence of even the slightest criticism of the principals and the misplaced focus on the opportunists, one might legitimately bring up the question whether the statement is not really an attempt by some in the medical profession to circle the wagons to protect colleagues who are likely to be guilty of criminal endangerment of public health. And given the lack of any criticism of Sanofi’s breath-taking wrongdoing, one might further raise the question if the “Doctors for Truth” statement is not really an attempt by the same people to also come to the defense of the pharmaceutical industry.

This is a legitimate issue since the industry’s relations with the medical profession everywhere in the world is very tight, with doctors and hospitals enjoying perks and donations from members of the pharmaceutical cartel that is cynically called “Big Pharma.”

Medical professionals serve on the international and local boards of the drug giants, and there is a revolving door between private practice, public health service, and corporate employment. For those passing through the revolving door, this translates into very lucrative income indeed, one that could be threatened by a more guarded public response to the products of the multi-billion-dollar industry.

In the interest of transparency, it might be good if the public were to demand that the “Doctors for Truth” fully disclose their professional associations, if any, to Sanofi and other members of the global pharmaceutical cartel, including their local affiliates and marketing arms. Thus concludes Dr. Bello.

Column of the Day

‘The Foreign Corrupt Practices Act of 1977 (FCPA) (15 U.S.C. § 78dd-1, et seq.) is a United States federal law known primarily for its main provision: Against bribery of foreign countries’ food management officials.’

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